Lyme treatment guidelines flawed, researcher says

CDC stands by endorsement of 28-day therapy

Nov. 18, 2012

Dr. Brian Fallon / Courtesy photo

Written by

Poughkeepsie Journal

Dr. Eva Sapi / Courtesy photo

More

ADVERTISEMENT

Two new studies provide support for the contention that the Lyme disease spirochete can survive treatment by antibiotics, while a third suggests, alternatively, that Lyme patients who relapse after treatment have simply been bitten again by an infected black-legged tick.

In an article in The Open Neurology Journal, an online medical publication, Dr. Brian Fallon, a Columbia University Lyme researcher, and his co-authors concluded that two of four antibiotic treatment trials showed patient improvement that current guidelines “overlook or inappropriately dismiss.”

The guidelines, which are based on the previously published studies, limit treatment to 28 days, holding that that is enough to eradicate the Lyme bacteria. However, the new study re-analyzed such things as sample size and methods used in each trial and concluded that measurements of patient improvement after continued antibiotic treatment were flawed.

“(A)pproximately 60 percent of patients with persistent post-treatment Lyme fatigue may experience meaningful but partial clinical improvement in fatigue,” the study concluded, noting the guidelines should be revised to show that some studies demonstrated improvement while others did not. While Fallon was a researcher on one of the studies critiqued in the article, a separate article published this year in the science journal Contemporary Clinical Trials, based on a different statistical analysis, also disputed conclusions that longer treatment had failed.

In response, the U.S. Centers for Disease Control and Prevention, which has endorsed the treatment guidelines, said it was aware of “potential limitations” of the studies but stood by the guidelines because of what it said are considerable side effects of long-term antibiotic treatment. (See CDC Q&A below.)

In another study, researchers at the University of New Haven in Connecticut discovered that the Lyme spirochete, called Borrelia burgdorferi, is capable of forming “biofilms” — basically a protective coating that serves in unfavorable conditions as a “potentially powerful survival mechanism.”

(Page 2 of 3)

The paper, by Dr. Eva Sapi and collaborators, was published in PLOS ONE, an online scientific journal, and demonstrated biofilm production on the spirochete under laboratory conditions. It concluded, “Biofilm formation by Borrelia species might play an important role in their survival in diverse environmental conditions.” In short, this suggests a way, for example, that the spirochete may survive antibiotic treatment.

A third study, published in the New England Journal of Medicine, studied 17 patients with chronic Lyme disease and found that genetic material extracted from Lyme spirochete rashes differed in each illness episode.

“Our data show that repeat episodes … were due to re-infection and not relapse,” the authors concluded.

Joseph Breen, who oversees Lyme disease research for the National Institutes of Health, which provided partial study funding, said the research provides “an important piece in the puzzle of trying to understand the infection overall.”

Officials of the Centers for Disease Control and Prevention declined comment on the re-infection study. Below are their responses to Poughkeepsie Journal questions about the agency’s stand on antibiotic treatment and the scope of what the agency calls an “endemic.” The responses were prepared by C. Ben Beard, Ph.D., and his team in the bacterial diseases branch, of which he is chief.

POUGHKEEPSIE JOURNAL: Does the CDC plan to reconsider its endorsement of guidelines that limit antibiotic treatment for Lyme disease to 28 days in light of new research?

CDC: In regard to the recent re-assessment of (four studies of repeated antibiotic treatment), we reviewed these articles when they were originally published and have been aware for some time of their potential limitations. However, it is one thing to say that these studies have limitations and quite another to conclude that they support long-term use of antibiotics. CDC has no reason to oppose long-term antibiotic therapy if it is shown to be clearly beneficial for these patients. It has not and the adverse effects are considerable, including but not limited to allergic reactions, fungal infections, gall bladder dysfunction, and death.

(Page 3 of 3)

CDC stands by our statement that the Infectious Disease Society of America treatment guidelines are “the best available synthesis of the medical literature currently available.” This is not just our conclusion. It is also the conclusion of an independent, mutually agreed upon panel that reviewed the guidelines in response to the Connecticut Attorney General Blumenthal’s agreement with Infectious Disease Society of America.

POUGHKEEPSIE JOURNAL: Is Lyme an epidemic anywhere in the U.S. in view of a 23 percent nationwide hike in the last two five-year blocks (2002-06 to 2007-11) and large increases in Northeastern states?

CDC:During 2006-2009, the total number of Lyme disease cases reported to CDC increased each year. … In 2010, however, confirmed cases decreased 25% ... as compared with 2009. … Among 12 high-incidence states in the Northeastern and mid-Atlantic regions, all but Virginia reported a decrease in confirmed cases.

In general, the CDC reserves the word “epidemic” for situations in which there has been an especially sudden and unexpected change. … We are not currently seeing a sudden or unexpected change in Lyme disease. We know that the disease is expanding into new geographic areas, but … some increases … can be attributed to changes in surveillance practices which result in an increased proportion of true cases being captured.

POUGHKEEPSIE JOURNAL: What is the magnitude of underreporting of Lyme disease?

CDC: CDC is conducting studies to determine the current degree of under-reporting. The 3-12 figure (namely that actual cases were three to 12 times higher) is from the 1990s. … (T)here have been substantial, documented improvements in surveillance over the last 15-20 years which make it likely an over-estimate. … The degree of under-reporting for Lyme disease is comparable to — or better than — most other diseases under national surveillance. … “Underreported” does not mean under-treated or under-diagnosed. Patients whose illnesses go unreported are nevertheless being diagnosed and treated.

POUGHKEEPSIE JOURNAL: Has the CDC had occasion to revisit research on Lyme disease that has led it to say that the two-tier tests “almost always” turn positive after a few weeks?

CDC: CDC revisits this issue regularly and stands by its recommendation of two-tier serologic (blood) testing. For clarity, we may add the word “untreated” to the statement as follows: “… patients who have had untreated Lyme disease for longer than 4-6 weeks, especially those with later stages of illness involving the brain or joints, will almost always test positive.” CDC welcomes the development, peer-reviewed validation, replication, and FDA clearance of new Lyme disease tests. CDC is very concerned, however, about the use of tests that have not been adequately validated and FDA-cleared. … We are concerned that patients with a wide range of other, potentially treatable diseases are being misdiagnosed with Lyme disease.